September 11, 2001 : Attack on AmericaTestimony of Dr. Frank Young - A Review of Federal Bioterrorism Preparedness Programs from a Public Health Perspective. Subcommittee on Oversight and Investigations; October 10, 2001

A Review of federal Bioterrorism Preparedness Programs from a Public Health Perspective.
Subcommittee on Oversight and Investigations
October 10, 2001
10:00 AM
2322 Rayburn House Office Building

Thank you for the opportunity of testifying before your committee concerning the "Federal Preparedness for Bioterrorism from a Public Health Perspective". As a microbiologist and a physician focusing on infectious disease, I have been involved in research on non-pathogenic and pathogenic organisms related to those used in bioterrorism for over a quarter of a century. In government I participated in the defense from the effects of organisms involved in bioterrorism since 1984 when I served as Commissioner of the Food and Drug Administration to 1996 when I completed my service as Director of the Office of Emergency Preparedness and the National Disaster Medical System. From 1993-1996, I represented the Department of Health and Human Services on the Council of Deputies of the National Security Council, coordinated the Emergency Support Function 8 for Health and Medical response in the Federal Response Plan and participated in many training exercises to test response to disasters caused by weapons of mass destruction. My testimony will focus on the reality of the threat, the two basic types of threats, the requirements for effective management; the progress made to date and additional needs for enhancement of our capabilities.

The call to testify before your Sub-committee came while I was preparing for an adult ministries class in the church where I serve as associate pastor. It was a remarkable kaleidoscope of ideas as I pondered the attributes of a Christian disciple from the Sermon on the Mount I taught last Sunday to my church (the Gospel of Matthew 5:1-15) as compared with terrorism-the essence of evil. The sinfulness of mankind is revealed in the wanton destruction of civilian life. None of the major world religions preach the violent slaughter of innocent people.

The Threat

Most experts in bioterrorism would agree that the threat is smaller than the use of bombs and bullets, but this low probability event is of high consequence. While a large number of microorganisms could be utilized, the more plausible organisms are summarized in attachment 1.[1] Of these, anthrax is the easiest to prepare and disseminate particularly in confined spaces. It also, under appropriate conditions, can produce the highest morbidity and mortality. A comprehensive analysis of the current threats can be obtained from the excellent publication of the Institute of Medicine and National Research Council entitled "Chemical and Biological Terrorism: research and development to improve civilian medical response.

Two general types of release can be perfected. First and easiest, is the release of organisms in an enclosed environment such as a building, subway or ship. Small amounts of microbes are required, the dispersal conditions are not so rigorous and the agent recycles in the air system until it settles out. The agent is also less exposed to harsh environmental conditions. This type of release is designed more to produce terror than a large kill. Second, the organisms can be released as an aerosol into the atmosphere through a spray such as a crop duster airplane, or a truck with an insect sprayer (fogger). The sprayers are more difficult as they require a dispersal agent to keep the particles below 10m to ensure particles are inhaled into the lungs. Effective release is highly dependent on climatic conditions. It is important to note that the Aum Shinriko was unsuccessful in causing death form an aerosol release.

Fortunately the United States has excellent medical capacity to the management of infectious disease. However, there is limited hospital surge capacity. The growth of managed care, cost containment procedures; reduction in hospital beds and reduction in hospital staffs has limited markedly the excess capacity of the health system in responding to large-scale emergencies. A visit to a metropolitan emergency room on a Saturday evening will show the strain on resources required for daily needs let alone an emergency. Systems need to be developed to make beds rapidly available.

The primary issues to be addressed are: intelligence to minimize surprise and interdict the terrorists; crisis response to mobilize investigative forces and consequence management. Frequently crisis and consequence management occur at the same time. Bioterrorism events will likely be discovered after a number of people have become sick or died therefore rapid response is of the essence. With appropriate commitment of resources and organization skills illness and death can be reduced 60-to100 fold but deaths will occur at the initial site of release and continue until the infectious agent(s) are brought under control.

Requirements of a robust system for defense against bioterrorism

1. An integrated Federal, State and local civil response system.

2. A single command and control system at the Federal level

3. A robust Public Health infrastructure that includes the military and civilian sectors.

8. Training of medical response system with particular emphasis on local response capacity using both exercises and distance learning

9. A regulatory system within FDA that can evaluate therapeutics using surrogate markers and sufficient resources to accomplish the reviews expeditiously.

Progress since the Gulf War

During the Gulf War, I had the responsibility for training the local fire-rescue and emergency response system for a possible anthrax attack. We had little of the above listed capacity. Together with William Clark, presentations were made on the various biologic agents and with the support of the Assistant Secretary for Health, James Mason, I stored sufficient medicine inside the beltway to treat 51,000 people for 48 hours with antibiotics. Liaison was established with both FBI and FEMA. The system was totally inadequate.

Following the Gulf war, The Public Health Service (PHS), through the Office of Emergency Preparedness which I directed sought the support of FEMA for the first Federal bioterrorism training exercise (CIVIX 93) that simulated an anthrax attack on a large metropolitan subway system. This exercise revealed widespread weaknesses in the response system at all levels. It also demonstrated the need to include military assets at USAMRIID and the research capacity of DARPA to develop certain applied research projects. However, attempts to obtain adequate funds to address the deficiencies were unsuccessful within the Administration and Congress.

The attack of the Aum Shinriko on the Tokyo subway system in 1995 with sarin led to middle of the night discussions during which I reported rapidly to Mr. Richard Clarke, National Security Council that the agent was most likely sarin based on the symptoms. The difficulties involved in preparing to defend against a coordinated attack on the United States and other countries are well described in the recent publication by Miller, Engelberg and Broad.[2] The magnitude of the Aum Shinriko operations and the discovery that they experimented unsuccessfully with anthrax provided a wake up call to our nation. In the aftermath of the incident, there was a great deal of activity led by Richard Clarke that culminated in PDD 39, and the designation of the PHS as the lead Federal Agency in consequence management for biologic agents. Broad Federal cooperation occurred in the meetings that I chaired and assignments were completed on time. Trust and close working relationships are required for success. We all recognized that we should not exchange business cards for the first time at the site of a disaster. The planning actions of representatives from American Red Cross, DOD, DOJ, EPA, FBI, FEMA, PHS, VA, and USDA resulted in the completion of the integrated Health and Medical Services Support Plan for the Federal response to terrorism in September 1995. Unfortunately, adequate funds for implementing this plan were not forth coming despite appeals both to the then Principle Deputy Assistant Secretary for Health and her staff and in the PHS and the Congress. There were two initiatives that were seminal and have had a marked impact on training nationally. First, the Secretary of DHHS made monies available for the first time to local communities enabling both local and integrated Federal, State and local training exercises to occur. Second, the Metropolitan Washington response agency (Council of Governments) wrote to President Clinton describing the inadequate preparation of the region. Subsequently, the Office of Emergency Preparedness with the advice of State and local health personnel developed a concept of Metropolitan Medical Strike Teams to augment the capability of local public safety, public health, fire rescue, hazmat and medical emergency responders to be able to address successfully biological and chemical terrorism.

The next major change in the preparedness system resulted from a concern by President Clinton. He concluded that there was weakness in the current response to bioterrorism based on world conditions and requested briefing from non-governmental experts. During the meeting with the President and selected senior staff, the Attorney General, the Secretary of Defense and the Secretary of DHHS, a comprehensive analysis of the current statue of preparedness and recommendations for improvement were presented. The President requested that the analysis be submitted expeditiously. The document with the attached budget is submitted as attachment 2. Particularly relevant was the focus on emergency response and research. The DOD, DHHS and DOJ were requested to examine their programs, propose enhancements to overcome the noted deficiencies and submit an appropriate budget. The positive response of the departments led to substantial improvements.

Progress since May 1998

The increased budget for the PHS has resulted in substantial improvements. However the most significant recent event was the appointment of Governor Tom Ridge as Director of Home Defense. If he is successful in developing a coordinated approach to the threat of terrorism in general and bioterrorism in particular, it will greatly improve the response. A coordinator in HHS for all of the former PHS agencies with budget authority and coordination responsibility could aid the Directors efforts.

Training has been greatly strengthened through the provision of funds to the States. The concept of Metropolitan Medical Strike Teams has been continued though renamed (Metropolitan Medical Response System). A total of 97 systems have been funded in cities or locales. Coordination between Federal and State and local public health agencies has been heightened through monies for joint training exercises. The National Disaster Medical System has been enhanced through additional development of teams that can respond to both chemical and bioterrorism.

The public health infrastructure at the local, State and Federal level is still not sufficiently robust. For example at the Federal level, the containment facilities and staff trained to study highly infectious pathogens at the BSL 2- 4 level in USAMRIID are inadequate to meet the needs for contained management of highly infected cases and research of pathogens. They need to be doubled in size. Similarly, the facilities at the Centers for Disease and Prevention and NIH are inadequate. Other regional facilities need to be developed. The public health laboratories, while able to diagnose bacterial infections, have insufficient facilities for viral diagnosis. Finally, there is insufficient graduate training in this field. The most experts who were involved in the bioterrorism field like myself are retired!

Most telling is the inability to diagnose infectious agents rapidly. The recent fatal case of anthrax in Florida is illustrative. It took at least 48 hours for the diagnosis. Probably classical culture and antibiotic sensitivities were employed. This is simply unacceptable. To have effective treatment to reduce toxemia, it is imperative to make the diagnosis more expeditiously through immunological means. Adequate laboratory facilities are required to meet emergency requirements. Anthrax may not always be easily diagnosed clinically, as textbook cases are rare in real life. Additionally, although USAMRIID and CDC and other state laboratories can do careful epidemiological work through plasmid determination or bacteriophage sensitivities, these too need to be done in hours not days. Public and private sector research and development and expeditious evaluation by FDA is required to meet these needs. Similarly, rapid detection of other an agents that could be used in bioterrorism is imperative.

Great progress has been made in developing stockpiles of antibiotics and other medical supplies. However the supply of vaccines against anthrax and smallpox remains insufficient. The production of vaccines needs to be accelerated and Federal facilities may be necessary if the private sector cannot respond adequately. Because most people will not be immune and antibiotic resistant strains can be utilized, there is a need for just in time therapy to neutralize toxin and microbial agents in bioterrorism. The Biotechnology Company Elusys on whose Board of Directors I serve is developing one such promising approach. This therapy can neutralize the anthrax toxin after exposure and when used in combination with antibiotics should be highly effective (attachment 3).

Surge capacity of the medical system has been enhanced but only marginal progress has been made since 1998. This is a highly significant though correctable deficiency.

Research on pathogenic model systems for the common infectious agents has proceeded but remains inadequate.

The ad hoc committee that reported to the President emphasizes the need for regulations to facilitate the development of therapeutic agents and diagnostic agents for organisms that cannot be tested in human volunteers. Because there are insufficient natural cases of infections with agents like smallpox and anthrax, it is imperative to evaluate these in appropriate animal models. Additionally, it was recommended that a special division be formed and funded to provide the personnel to expeditiously determine the safety and efficacy of such therapies. FDA proposed a rule Docket No. 98N-0237 "New Drug and Biological Drug Products; Evidence Needed to Demonstrate Efficacy of New Drugs for use against Lethal of Permanently Disabling Toxic Substances When Efficacy Studies in Humans Ethically Cannot Be Conducted (FR Vol. 64: 53960-53970). The comment period closed December 20,1999, comments have been posted on the FDA web site however the rule is languishing. This rule is important because it would enable FDA to approve for marketing on the basis of appropriate well-controlled animal studies.

Urgent Recommendations

When I managed the emergency medical system there were difficulties in: understanding what to do, convincing the government to fund the infrastructure, and developing a system to coordinate the major agencies in PHS, DOD, VA FBI and FEMA. Much progress has been made since 1995 in addressing the response to terrorism with weapons of mass destruction. Funds can now be allocated to enhance the response system thereby saving many lives. Although there are especial nuances among them, the response to biological terrorism must be viewed in concert with an all hazards response system. Based on past professional experience, I urge the following recommendations for immediate implementation.

1. Develop a command and control system for Public Health that interfaces seamlessly with the Office of the Director of Home Defense and integrates all of the relevant organizations in the civilian agencies of government, the military and the private sector.

2. Enhance the rapid diagnosis system through the development of rapid immunological procedures. The recent delays in identifying the organism in Florida illustrate this need. Local laboratories can be overwhelmed by requests for mass screening. Therefore, it is necessary to ensure that communities have access to containment laboratories and surge capacity to meet large diagnostic loads.

3. Finalize the FDA regulation on Drugs to treat diseases where ethical considerations prevent the use of human subjects. The proposed regulation is Docket No. 98N-0237 "New Drug and Biological Drug Products; Evidence Needed to Demonstrate Efficacy of New Drugs for Use Against Lethal of Permanently Disabling Toxic Substances When Efficacy Studies in Humans Ethically Cannot Be Conducted (FR Vol. 64: 53960-53970). Provide 2-million dollars/ year for FDA to meet this critical mission.

4. Augment the mass casualty response system through:

Augmentation of the medical systems in the National Guard to enable them to rapidly deploy to the disaster site.

Creation of a dedicated health disaster personnel system with 750 officers within the Commissioned Corps of the Public Health Service under the direction of the Secretary and the Surgeon General. While these physicians, nurses, epidemiologists and support personnel can work in agencies while not deployed their primary responsibility is to the emergency management

Support training of individuals capable to manage the medical consequences of weapons of mass destruction both in the military and civilian sectors.

Training of medical and environmental health personnel through distance learning and exercises to ensure each community can respond appropriately. The excellent course at USAMRIID has trained over 50,000 people

Develop a similar civilian training program for all hazards

Develop an integrated system of field hospitals and identified facilities that can be used for mass casualty management. DOD has only approximately 5 such units and the equipment for field hospitals in DHHS is inadequate to meet the civilian need specially since the military units may be on deployment.

Augment the containment facilities in hospitals to ensure that the hospital will not be rendered useless through needless contamination.

Ensure that the emergency response teams can be protected through proper equipment and protective clothing. One recent development is a shirt developed through a research grant from DARPA that can determine heart rate, respiratory rate, temperature, blood oxygenation and locate people under 60-80 feet of rubble through geopositioning and two way communications (attachment 4). This would enable trapped workers to be located

Provide sufficient training in containment and decontamination of infectious agents within the environment. The emergency response capacity of EPA should be enhanced.

5. Ensure sufficient medicines to respond to mass casualties through stockpiles at strategic locations. Where supplies are insufficient the Federal government should support research into new therapies and production of just in time immunotherapies and vaccines.

6. Mass death management. The events in Oklahoma City and the World Trade Center have taught us how difficult it is to identify bodies. Massive deaths from a major terrorist attack require sensitive treatment of the remains of loved ones.

7. Development of a reserve system of grief counselors and chaplains that can be trained through distance education and local exercises. As a Pastor, I can attest that at a time of mass casualties, the faith and the emotional well-being of the victims may be fragile and in need of significant support.

8. Media communications must be accurate and informative. Public Health officials should be trained and exercised in communication. The confusion of facts in the recent Florida anthrax case is an example of this need.

9. Support genomic research to enable rapid analysis of novel organisms including those with mutations to antibiotic resistance and genetically engineered toxin production.

10. Support development of " just in time immune therapies" to treat the potential threat agents

Summary

While the threat of bioterrorism is a significant, it can be overcome through coordinated civil defense, a robust public health system and research on the genomes and mechanism of pathogenicity of threat agents. Of particular need are methods of rapid diagnosis, enhanced containment facilities and new modalities of therapy. It is important to note that the proposed measures will strengthen our response to emerging pathogens as well as meet the threat of bioterrorism. Thus funds to address the issues identified in this testimony will be well spent.